Laterally-Actuated Dispenser with One-Way Valve for Storing and Dispensing Substances

ABSTRACT

A dispenser for dispensing a substance, such as a pharmaceutical, ophthalmic, dermatological, cosmeceutical, cosmetic or other product, has a body with a variable-volume storage chamber for storing the product. A dispensing portion of the dispenser is connected with the body and has a compression chamber in fluid communication with the storage chamber for receiving substance therefrom, and an outlet aperture coupled in fluid communication with the compression chamber. A one-way valve of the dispenser includes an axially-extending valve seat and an axially-extending flexible valve cover seated on the valve seat and defining a normally-closed, axially-extending seam therebetween forming a fluid-tight seal between the valve cover and valve seat. The flexible valve cover is movable relative to the valve seat and the seam is connectable in fluid communication with the outlet aperture to allow the passage of substance through the seam and out of the dispenser. The dispenser further comprises a manually-engageable actuator connected to the dispensing portion movable between first and second positions to dispense substance within the compression chamber through the outlet aperture, and an integral, dome-shaped spring for biasing the actuator in a direction from one of the first and second positions toward the other.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.11/237,599 filed Sep. 27, 2005, titled “Laterally-Actuated Dispenserwith One-Way Valve for Storing and Dispensing Metered Amounts ofSubstances,” now U.S. Pat. No. 7,665,923 issued Feb. 23, 2010, andclaiming priority to U.S. Provisional Application No. 60/613,583, filedSep. 27, 2004, titled “Laterally-Actuated Dispenser with One-Way Valvefor Storing and Dispensing Metered Amounts of Substances” and U.S.Provisional Application No. 60/699,607 filed Jul. 15, 2005 titled“Laterally-Actuated Dispenser with One-Way Valve for Storing andDispensing Metered Amounts of Substances,” each of which is herebyexpressly incorporated by reference in its entirety as part of thepresent disclosure as if fully set forth herein. This patent applicationalso contains subject matter similar to that disclosed in the commonlyassigned U.S. Design patent application No. 29/214,062, filed on Sep.27, 2004 titled “Dispenser with Laterally-Actuated Dispensing Valve,”now patent No. D543,469 issued May 27, 2007, which is hereby expresslyincorporated by reference as part of the present disclosure.

FIELD OF THE INVENTION

The present invention relates to dispensers for containing anddispensing fluids and other substances, such as pharmaceutical,cosmeceutical, and cosmetic products, and more particularly, todispensers for holding multiple doses of such fluids and othersubstances, and that include one-way valves for hermetically sealing thesubstances within the dispensers, and actuators for actuating pumpswithin the dispensers and dispensing metered doses of substances throughthe one-way valves.

BACKGROUND INFORMATION

Prior art dispensers for storing and dispensing multiple doses ofsubstances, such as cosmetic dispensers for dispensing, for example,liquid lipstick or eye shadow, ophthalmic dispensers for dispensingophthalmic products, such as eye drops, and pharmaceutical dispensersfor dispensing pharmaceutical products, typically do not store theproduct, which may take the form of a liquid, cream, gel, suspension orother format, in a hermetically sealed storage chamber. In addition,such dispensers may be exposed to, and/or are applied to a user's facialor other body surfaces that may contain dirt, germs, bacteria or otherunwanted contaminants. Such contaminants can penetrate through thedispensing openings in the dispensers and, in turn, contaminate the bulkof the products stored within the dispensers. As a result, thecontaminants can be passed from one user to another or otherwise causeunhealthy conditions with further usage of the dispensers. Further,because the products stored within the dispensers are exposed to air,the products can degrade or spoil, and/or require preservatives toprevent such degradation and/or spoilage from occurring. In somecircumstances, preservatives can cause allergic and/or other undesirableor negative reactions, such as unwanted dermatological reactions, orirritation of the eyes, skin or other tissues.

In other known prior art dispensers including storage chambers forstoring multiple doses of substances, pumps for pumping the substances,and one-way valves for dispensing the pumped substances, there aremultiple pieces required to form these parts and perform theirfunctions. Such multiple parts can lead to manufacturing complexitiesand undesirable expense.

It is an object of the present invention to overcome one or more of theabove-described drawbacks and/or disadvantages of the prior art.

SUMMARY OF THE INVENTION

The present invention is directed to a dispenser for dispensing asubstance. In some embodiments, the dispenser comprises a body defininga variable-volume storage chamber for storing the substance, and adispensing portion connected with the body. In certain embodiments, thedispensing portion defines a bore coupled in fluid communication withthe storage chamber for receiving substance therefrom, and an outletaperture coupled in fluid communication with the bore. A one-way valveof the dispenser includes an axially-extending valve seat and anaxially-extending flexible valve cover seated on the valve seat anddefining a normally-closed, axially-extending seam therebetween forminga fluid-tight seal between the valve cover and valve seat. The flexiblevalve cover is movable relative to the valve seat, and the seam isconnectable in fluid communication with the outlet aperture to allow thepassage of substance through the seam and out of the dispenser. Thedispenser further comprises an actuator and piston assembly including apiston receivable within the bore, a manually-engageable actuatorconnected to the piston for moving the piston between first and secondpositions relative to the bore to dispense substance within the borethrough the outlet aperture, and a spring coupled to at least one of thepiston and the actuator for biasing the piston in a direction from oneof the first and second positions toward the other.

Preferably, the actuator is located laterally with respect to theone-way valve. In one such embodiment, the piston defines a drive axisextending between the first and second positions, and the piston driveaxis is oriented transverse to an axis of the valve. In one embodimentof the present invention, the piston drive axis is oriented at an angleof about 90° relative to the one-way valve axis. In another suchembodiment, the piston drive axis is oriented at an acute angle relativeto the one-way valve axis.

In the currently preferred embodiments of the present invention, thespring is approximately dome shaped. Also in some embodiments, thespring, piston and valve cover are formed integral with each other. Inone such embodiment, the spring, piston and valve cover are molded inone piece.

In some embodiments of the present invention, the actuator and pistonassembly defines a needle penetrable and resealable portion that permitsthe variable-volume storage chamber to be needle filled with a substancetherethrough, and that allows the resulting needle hole to be thermallyresealed, such as by application of laser energy thereto. In otherembodiments of the present invention, a plunger is slidably receivedwithin the body of the dispenser and forms the variable-volume storagechamber, and includes a needle penetrable and resealable stopper or likeportion that permits the variable-volume storage chamber to be needlefilled with a substance therethrough, and that allows the resultingneedle hole to be thermally resealed, such as by application of laserenergy thereto.

In other embodiments of the invention, a first means forms thevariable-volume chamber for storing the substance, and second means iscoupled in fluid communication with the first means for dispensingmetered dosages of substance, which third means for receiving a portionof the substance stored in the first means. Fourth means forms anexternal portion of the dispenser and is coupled in fluid communicationwith the second means (i) for normally sealing the second means along anannular, axially-extending seam and preventing the dispensing ofsubstance below a threshold pressure through the second means, and (ii)for substantially sequentially opening the seam in an axial directionthereof to allow the passage of substance at a pressure greater than thethreshold pressure through the second means and out of the dispenser.Fifth means is manually engageable and laterally depressible betweenfirst and second positions relative to an elongated axis of thedispenser for pressurizing the substance in the third means, which isconnectible in fluid communication between the first means and thefourth means. During movement of the fifth means in the direction fromthe second position toward the first position, the first means is influid communication with the third means, and substance can flow fromthe first means into the third means. During movement of the fifth meansin the direction from the first position toward the second position, thethird means is not in fluid communication with the first means and aportion of the fifth means extends into the third means, whichpressurizes substance within the third means above an opening pressureof the fourth means and, in turn, dispensing the substance through thefourth means and out of the dispenser.

In further embodiments, the dispensing portion defines a compressionchamber coupled in fluid communication with the storage chamber toreceive substance therefrom, and an outlet aperture is coupled in fluidcommunication with the compression chamber. The dispensing portion has amanually-engageable actuator mounted on it, which has a manuallyengageable surface on an external side of the actuator and a compressionsurface on an internal side of the actuator. The manually engageablesurface is manually depressible between first and second positions toactuate the dispenser and allow the passage of substance through theone-way valve, as discussed above, and is normally biased in thedirection from the second position toward the first position.

One advantage of the present invention is that the dispenser can storemultiple doses of substances, such as pharmaceutical, cosmeceutical,cosmetic, or ophthalmic products, in a hermetically sealed, sterilecondition throughout the shelf life and usage of the dispenser. Further,currently preferred embodiments of the dispenser can provide metereddoses of the substance with a simple, one-handed actuation motion. Yetanother advantage of the currently preferred embodiments of the presentinvention is that the valve cover and the actuator and piston assemblycan be molded in one piece, and the body, dispensing portion and valveseat likewise can be molded in one piece, thus permitting asignificantly reduced number of parts in comparison to prior artdispensers, and thereby reducing the complexity and manufacturingexpense in comparison to such dispensers. A still further advantage ofthe present invention is that the actuator and piston assembly, or theplunger or other component forming the variable-volume storage chamber,can define a needle penetrable and thermally resealable portion, therebypermitting the dispenser to be needle filled and laser resealed.

Other objects and advantages of the present invention, and/or of thecurrently preferred embodiments thereof, will become apparent in view ofthe following detailed description of the currently preferredembodiments and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional view of a first embodiment of a dispenser,in an unactuated state, which is the rest position.

FIG. 2 is a cross-sectional view of the dispenser of FIG. 1 showing theactuator and piston assembly in an actuated state, which is thefully-depressed position.

FIG. 3 is a perspective view of the dispenser of FIG. 1.

FIG. 4 is a perspective view of the dispenser of FIG. 1 with the capremoved.

FIG. 5 is a partial, cross-sectional view of a second embodiment of adispenser.

FIG. 6 is a partial, cross-sectional view of the dispenser of FIG. 5showing the actuator and piston assembly in a partially actuatedposition.

FIG. 7 is a partial, cross-sectional view of the dispenser of FIG. 5showing the actuator and piston assembly in a fully-actuated position.

FIG. 8 is a top view of a third embodiment of a dispenser.

FIG. 9 is a cross-sectional view of the dispenser of FIG. 8.

FIG. 10 is a top view of a fourth embodiment of a dispenser.

FIG. 11 is a cross-sectional view of the dispenser of FIG. 10.

FIG. 12 is a cross-sectional view of a fifth embodiment of a dispenser.

FIG. 13 is a top view of the dispenser of FIG. 12.

FIG. 14 is a cross-sectional view of a sixth embodiment of a dispenser.

FIG. 15 is a cross-sectional view of a seventh embodiment of adispenser.

FIG. 16 is a cross-sectional view of an eighth embodiment of adispenser.

FIG. 17 is a cross-sectional view of a ninth embodiment of a dispenser.

FIG. 18 is a cross-sectional view of tenth embodiment of a dispenser.

FIG. 19 is a cross-sectional view of an eleventh embodiment of adispenser.

FIG. 20 is a cross-sectional view of a twelfth embodiment of adispenser.

FIG. 21 is a cross-sectional view of a thirteenth embodiment of adispenser.

FIG. 22 is a partial, perspective view of the valve cover of thedispenser of FIG. 21.

FIG. 23 is a partial, perspective view of an alternative embodiment ofthe plunger of the dispenser of FIG. 21.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Referring to FIGS. 1-4, a dispenser embodying the present invention isindicated generally by the reference numeral 10. The dispenser 10 isparticularly suitable for dispensing metered amounts of fluids and othersubstances, such as pharmaceutical, cosmeceutical, cosmetic, andophthalmic products. However, as may be recognized by those of ordinaryskill in the pertinent art based on the teachings herein, the dispenser10 may be adapted to dispense any of numerous different types of fluidsor other substances that are currently known, or that later becomeknown. As shown typically in FIG. 1, the dispenser 10 includes a body 12defining a variable-volume storage chamber 14 for storing the substance,such as a pharmaceutical, cosmeceutical, cosmetic and ophthalmicproduct. A dispensing nozzle or portion 16 is connected with the body 12and defines a bore 18 coupled in fluid communication with the storagechamber 14 for receiving the stored substance therefrom, and at leastone outlet aperture 20 coupled in fluid communication with the bore 18.An actuator and piston assembly 22 is receivable within the bore 18, anda dispensing nozzle or one-way valve 24 is mounted on the dispensingportion 16 for dispensing metered amounts of the stored substancetherethrough.

The one-way valve 24 includes an axially-extending valve seat 26, and anaxially-extending flexible valve cover 28 seated on the valve seat anddefining a normally-closed, axially-extending seam 30 therebetweenforming a fluid-tight seal between the valve cover 28 and valve seat 26.As described further below, the flexible valve cover 28 is movablerelative to the valve seat 26, and the seam 30 is connectable in fluidcommunication with the outlet aperture 20 to allow the passage ofproduct through the seam and out of the dispenser.

The actuator and piston assembly 22 includes a manually engageableactuator 32, and a piston 34 coupled to the actuator 32 for moving thepiston within the bore 18 and dispensing a predetermined amount ofproduct within the bore through the outlet aperture 20 and one-way valve24. The piston 34 is movable between a first or rest position, as showntypically in FIG. 1, with the piston tip 36 spaced away from the outletaperture 20 and defining a compression chamber 38 therebetween, and asecond fully-activated position, shown typically in FIG. 2, with thepiston tip 36 located adjacent to, or in contact with a stop surface 40formed at the downstream end of the bore 18 for dispensing apredetermined amount of substance within the compression chamber throughthe outlet aperture 20. As can be seen, the actuator and piston assembly22 is formed integral with the valve cover 28. In the illustratedembodiment of the present invention, the actuator and piston assembly 22is molded in one piece with the valve cover 28. As also shown, theactuator 32 is laterally positioned with respect to the one-way valve24. The piston 34 defines a drive axis extending between the restposition of FIG. 1 and the fully-actuated position of FIG. 2, and thepiston drive axis is oriented transverse to the axis of the one-wayvalve 24 and body 12. In the illustrated embodiment of the presentinvention, the piston drive axis is oriented at about 90° relative tothe axis of the one-way valve and body. However, as described furtherbelow, the drive axis may be oriented at any of numerous angularorientations in order to facilitate the manufacture of the dispenser, tofacilitate manual manipulation of the dispenser, or otherwise to improvethe ergonomics of the dispenser.

As indicated above, the one-way valve 24 includes a relatively rigidvalve seat 26 and a flexible valve cover 28 mounted over the valve seatand defining the axially elongated, annular seam or interface 30therebetween. As described further below, the actuator and pistonassembly 22 forces a metered dose of fluid or other substance atsufficient pressure to open the valve (the “valve opening pressure”) andforce the fluid or other substance through the valve interface 30 andout of the dispenser. The valve cover 28 preferably forms aninterference fit with the valve seat 26 to thereby form a fluid-tightseal in the normally closed position and, in turn, maintain the fluid orother substance within the dispenser in a sterile and hermeticallysealed condition. As shown typically in FIGS. 1 and 2, the valve cover28 defines a substantially tapered cross-sectional shape moving in theaxial direction from the interior toward the exterior of the valve. Thisconfiguration requires progressively less energy to open each respectiveannular portion of the valve when moving axially from the interiortoward the exterior of the valve. Alternatively, or in combination withthe tapered valve cover, the valve seat may define an outer diameterthat progressively or otherwise increases in the axial direction towardthe valve tip, to provide the same or similar effect. As a result, oncethe base of the valve is opened, the pressure is sufficient to cause therespective axial segments of the valve cover 28 to progressively openand then close after passage of fluid therethrough when moving in theaxial direction toward the valve tip to dispense a metered dose. Also,at any time when dispensing a metered dose, preferably any one of aplurality of different substantially annular segments of the valve cover28 engages the valve seat 26 to maintain a fluid-tight seal across thevalve 24, and thereby prevent ingress through the valve of germs,bacteria or other unwanted substances and into the storage chamber 14.

The valve seat 26 and bore 18 are formed integral with the body 12 andare formed of a relatively rigid material. The dosage or compressionchamber 38 is formed between the piston tip 36 and a stop surface 40formed on the axially inner side of the valve seat 26. A fluidpassageway 42 extends between the piston tip 36 and the inlet to thebore 18 and, when the piston 34 is located in the rest position, asshown in typically FIG. 1, the fluid passageway 42 is coupled in fluidcommunication between the dosage chamber 38 and storage chamber 14 forpermitting the flow of fluid or other substance from the storage chamberinto the dosage chamber.

The bore 18 defines a diameter or width selected to cooperate with thepiston tip 36 to define the volume of the dosage chamber 38 and thus thevolume of the dosage dispensed. The axial extent of the bore 18 definesa compression zone within which the fluid or other substance iscompressed by the piston 34 and, in turn, forced through the one-wayvalve 24. As described further below, the piston 34 is movable relativeto the bore 18 from (i) a rest position, shown typically in FIG. 1, withthe piston tip 36 laterally spaced relative to the inlet end of the bore18 to allow fluid communication between the storage chamber 14, fluidpassageway 42, and dosage chamber 38; (ii) to a fully-actuated position,shown typically in FIG. 2, with the peripheral surface of the tip 36 ofthe piston 34 received within the bore 18 and the distal end of thepiston located adjacent to, or in contact with, the stop surface 40 ofthe bore; and (iii) back again to the rest position of FIG. 1 uponrelease of the actuator 32. As shown in FIG. 2, the peripheral surfaceof the piston tip 36 slidably contacts, and preferably forms aninterference fit with the bore 18 to thereby form a substantiallyfluid-tight seal therebetween. However, as indicated further below, suchan interference fit or fluid-tight seal may not be required for allembodiments or applications of the dispenser.

In the rest position (FIG. 1) and at the start of the inner stroke ofthe piston 34 (i.e., in the direction from the inlet of the bore towardthe stop surface 40), the compression zone 38 is in fluid communicationwith the fluid passageway 42 and storage chamber 14, and thus fluid ispermitted to flow both forwardly in front of the piston, and rearwardlyback over the sides of the piston tip 36. Then, when the sealing surfaceof the piston tip 36 slidably engages the bore 18, a substantiallyfluid-tight seal is formed therebetween, trapping a substantiallyprecise volume of fluid within the compression zone 38 and forcing themetered volume of fluid through the valve 24. If desired, the tip of thepiston and/or the compression zone may be shaped to facilitate suchseal. For example, the tip of the piston may define a substantiallyfrusto-conical, cross-sectional shape. Further, the bore may define areduced cross-sectional diameter or width forming the compression zone.In addition, the materials of the piston tip and bore may be selected toachieve such characteristics. For example, the piston tip and portion ofthe bore forming the compression zone may be formed of relatively rigidplastic materials that are dimensioned to form a fluid-tight annularseal when slidably engaging one another.

In the illustrated embodiments of the present invention, the dispenserbody is made of a relatively hard plastic material, such as any of theplastics sold under the trademarks Topaz™, Surlyn™, and Zeonex™. Thevalve cover 28 and integral actuator and piston assembly 22, on theother hand, is preferably made of an elastomeric material that isrelatively soft in comparison to the body 12 and valve seat 26. Forexample, the valve cover 28 and integral actuator and piston assembly 22may be made of a polymeric material, such as one of the materials soldunder the trademarks Kraton™ or Santoprene™ (e.g., Santoprene 8211-35(shore 35 hardness) or 8211-55 (shore 55 hardness)), or a vulcanizedrubber or other polymeric material. In addition, as described furtherbelow, in some currently preferred embodiments of the present invention,at least the actuator 32 and/or piston 34 (or a needle penetrable regionthereof) is made of a needle penetrable and thermally resealablethermoplastic material. However, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, thesematerials are only exemplary, and numerous other materials that arecurrently known, or that later become known for performing the functionsof the components described herein equally may be used.

As described further below, the illustrated embodiment of the presentinvention includes a single outlet aperture 20 for delivering themetered dosage. If desired, additional outlet apertures may be added(e.g., a second outlet aperture of the same or different sizediametrically opposed to the illustrated aperture 20), or the aperture20 may be moved to a position other than that shown (e.g., the singleoutlet aperture may be located on the opposite side of the valve seatrelative to that shown).

As shown in FIG. 2, the manually-engageable actuator 32 defines asubstantially-dome shaped spring 44 for normally biasing the piston 32away from the outlet aperture 20 and into the rest position, as shown inFIG. 1. One advantage of the substantially dome-shaped configuration isthat the dome shape imparts lateral (or radial) and axial forces to thepiston 34 to facilitate maintaining sufficient force to drive the pistonfrom the fully-actuated position (FIG. 2) to the rest or ambientposition (FIG. 1) throughout the shelf-life and usage of the dispenser10. Yet another advantage of the illustrated embodiment of the presentinvention is that by forming the spring integral with the actuator andpiston, a separate part that otherwise would be required to bias thepiston, is eliminated. However, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, theintegral spring 44 of the actuator 32 may take any of numerous differentshapes and/or configurations, and/or may be formed of any of numerousdifferent materials, that are currently known, or that later becomeknown for performing the function of the spring as described herein. Forexample, the spring may define a shape other than a dome shape, or maynot be formed integral with the bladder or the valve member. Forexample, the spring could take the form of a coil or other type ofspring, that may be made of metal, plastic, or any of numerous othermaterials, for biasing the piston as described herein. Also, the shapeand/or material of construction of the spring may be selected to controlthe spring force applied to the piston.

As indicated in FIG. 2, the manually-engageable portion 32 of theactuator is axially depressible inwardly against the bias of thedome-shaped spring 44 to drive the piston 34 from the rest positionshown in FIG. 1 to the fully-actuated position shown in FIG. 2. Asdescribed above, this inner stroke of the piston 34 forces apredetermined amount of substance through the one-way valve 24 and ontoan applicator surface 46 formed by the distal end portions of the valvecover 28 and valve seat 26. Then, when the user releases themanually-engageable portion 32, the dome-shaped spring 44 drives thepiston assembly 34 in a return stroke from the fully-actuated positionshown in FIG. 2 to the rest position shown in FIG. 1. On the returnstroke, a vacuum is created in the dosage chamber 38, which then pullsthe fluid or other substance contained within the storage chamber 14into the dosage chamber 38 such that the substance flows through thepassageway 42 and into the dosage chamber.

As shown, the applicator surface 46 defines a curvilinear contour tosubstantially conform to the contour of an application surface, such asfacial tissue. In the illustrated embodiment, the applicator surface 46defines a curvilinear contour designed to emulate the tip of a finger,and is particularly suitable for applying an eye shadow, concealer orother cosmetic product, or a dermatological or pharmaceutical productthat is applied to the skin. Alternatively, the contour may be shaped toconformably contact a user's lips for purposes of applying a metereddose of liquid lipstick, other cosmetic, pharmaceutical, or othercosmetic substance thereto. For example, the applicator surface may takeany of a variety of different forms designed to substantiallyconformably contact a user's eyelids, eyebrows, eyelashes, cheeks,toenails, fingernails, etc., or to deliver fluids or other substances ina desired manner, such as a desired drop size or in a desired spraypattern. As described further below, the applicator surface may beshaped to effectively deliver ophthalmic products, such as eye drops, ina manner that releases the drop at a substantially predeterminedlocation on the applicator surface, and that allows substantially theentire dosage to be released, to thereby facilitate a substantiallyconsistent drop size or volume from one dosage to the next.Alternatively, as described further below, the dispensing tip may beconfigured to deliver substances, and preferably metered dosages of suchsubstances, to any desired body surface or cavity, including, forexample, dispensing tips that are configured to deliver metered dosagesto the nasal, ear (i.e., otic delivery), vaginal, penis and/or analcavities, dispensing tips configured to deliver metered dosages to thescalp, or dispensing tips configured to deliver metered dosages tofingernails and/or toe nails, including dispensing tips configured todeliver substances underneath the nails, on the tops of the nails, or tothe cuticles of the nails. Accordingly, as may be recognized by those ofordinary skill in the pertinent art based on the teachings herein, thespecific shape and/or configuration of the dispensing tip and/or of theapplicator surface of the dispensing tip may take any of numerousdifferent shapes or configurations that are currently known, or thatlater become known for performing any of numerous different functions ofthe dispensing tip or applicator surface of the dispensing tip, and/orto address the requirements of any of numerous different applications ofthe dispensers for delivering any of numerous different substances thatare currently known or that later become known.

One advantage of the currently preferred embodiments of the presentinvention, is that once a metered dosage is dispensed, the piston tip 36returns to its rest position, as shown typically in FIG. 1, and thussubstantially equalizes the pressure in the compression chamber 38 andthe storage chamber 14. As a result, the product does not continue toflow through the valve 24. Thus, residual seepage of the product orother substance through the dispensing valve 24 may be avoided. Yetanother advantage of the dispenser of the present invention, is that thebulk of the product remains hermetically sealed in the storage chamber14 throughout the shelf life and usage of the dispenser. Yet anotheradvantage of the dispensers of the present invention is that the one-wayvalve 24 substantially prevents any germs, bacteria or other unwantedsubstances from entering the dispenser and contaminating the bulk of theproduct contained within the storage chamber 14. Accordingly, ifdesired, the dispensers of the present invention may be used to storeand dispense multiple doses of sterile substances and/orpreservative-free substances.

The dispenser 10 further includes a piston or plunger 48 that isslidably received within the body 12 and axially spaced relative to theactuator and piston assembly 22 to define the variable-volume storagechamber 14 therebetween. The plunger 48 includes at least one, andpreferably two axially spaced, outer annular sealing members or portions50 that sealingly engage the inner wall 52 of the body 12 to form afluid-tight seal therebetween. The sealing members or portions 50 may beformed integral with the plunger 48, such as by forming thereon annularprotuberances, as shown, or may be formed by sealing members, such aso-rings or other sealing members, that are received within correspondinggrooves or recesses formed in the plunger. As the integral actuator 32and piston 34 is progressively actuated, the plunger 48 slides forwardlywithin the dispenser body 12 (or in the direction of right to left inFIGS. 1 and 2) due to the suction forces exerted thereon as the fluid orother stored substance is dispensed from the variable-volume storagechamber 14. The dispenser 10 further includes a casing 54 thatsubstantially encloses the body 12, and defines a substantially oblongor oval window 56 therethrough. In the illustrated embodiment, the body12 is transparent, or otherwise substantially see-through, to allow auser to look through the window 56 and determine the amount of storedsubstance remaining within the variable-volume storage chamber 14. Thecasing 54 and/or body 12 defines one or more apertures (not shown)formed therethrough and located on the opposite side of the plunger 48relative to the one-way valve 24 to allow the flow of air therethroughand, in turn, permit the plunger 48 to slide inwardly upon dispensingthe fluid or other substance from the variable-volume storage chamber14.

In the illustrated embodiment, the plunger 48 is made of a relativelyresilient plastic material, such as one of the plastics sold under thetrademark Santoprene™ (e.g., Santoprene 8211-35 (shore 35 hardness) or8211-55 (shore 55 hardness)). As may be recognized by those of ordinaryskill in the pertinent art based on the teachings herein, thesematerials are only exemplary, and may be changed as desired or otherwiserequired by a particular application. For example, in applicationsrequiring low sorption, the plunger 48 and dispenser body 12 may beformed of a relatively low sorptive material, such as a relatively hardplastic, including one or more of the plastics sold under the trademarkTopaz™. As described further below, the plunger 48 may include a needlepenetrable and resealable stopper or like portion that permits thevariable-volume storage chamber to be needle filled with a substancetherethrough, and that allows the resulting needle hole to be thermallyresealed, such as by application of laser energy thereto.

The plunger 48 defines a substantially flat inner surface 47, and asubstantially conical tapered portion 49 extending between the innersurface 47 and the annular sealing surfaces 50. As can be seen, theinner end of the body 12 defines a substantially conically-tapered wall51, and a reduced-diameter portion 53 extending between theconically-tapered wall 51 and the fluid-passageway 42. When thevariable-volume storage chamber 14 is substantially emptied of thesubstance stored therein, the flat surface 47 of the plunger is receivedwithin the reduced-diameter portion 53, and the conically-taperedportion 49 is moved axially adjacent to, or into engagement with theconically-tapered wall 51 of the body 12. One advantage of thisconfiguration is that it substantially eliminates any dead volume in thedispenser and thus any waste of product stored therein.

The dispenser 10 further comprises an approximately annular securingmember 58 coupled to the body 12 and fixedly securing the valve cover 28thereto. The securing member 58 defines a first aperture 60 on one endthereof, and a second aperture 62 located laterally respect to the firstaperture 60 and extending through a side wall thereof. The one-way valve24 extends through the first aperture 60, and the manually-engageableportion 32 of the actuator 22 and integral dome spring 44 extendlaterally through the second aperture 62. As shown in FIG. 1, thesecuring member 58 includes an annular, tapered flange 64 that projectsradially inwardly on the inner end of the securing member, and the body12 defines a corresponding annular groove 66 that receives therein theannular tapered flange 64 to fixedly secure the securing member to thebody. The annular base portion 68 of the flexible valve cover 28 extendsaxially between the securing member 58 and the body 12, and includes anannular flange 70 on the inner end thereof that is received within acorresponding annular groove 72 formed in the securing member 58 tofixedly secure the flexible valve cover 28 to the body 12. Asubstantially cylindrical cap 74 is slidably received over the one-wayvalve 24 to enclose the dispensing tip during non-use. As can be seen,the securing member 58 defines on its inner end a peripheral lobe 76that is received within a corresponding annular groove formed on theinterior of the cap 74 to releaseably secure the cap to the body 12. Asmay be recognized by those of ordinary skill in the pertinent art basedon the teachings herein, the securing member 58 may be formed integralwith the valve cover 28 and actuator and piston assembly 22 such thatall components are molded in one piece, or alternatively, the securingmember may be over-molded to the valve cover actuator and pistonassembly (or vice versa).

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, the variable-volume storage chamber 14may be formed in any of numerous different ways that are currentlyknown, or that later become known, including, for example, by using arelatively flexible bladder mounted within a relatively rigid body, orby using a collapsible tube. The variable-volume storage chambers formedwith a flexible bladder may be constructed in accordance with theteachings of the following co-pending patent application which isassigned to the Assignee of the present invention, and is herebyexpressly incorporated by reference as part of the present disclosure:U.S. application Ser. No. 10/843,902, filed May 12, 2004, titled“Dispenser and Apparatus and Method for Filling a Dispenser”.

Similarly, the variable-volume storage chambers formed by a collapsibletube may be constructed in accordance with the teachings of thefollowing co-pending patent applications which are assigned to theAssignee of the present invention, and are hereby expressly incorporatedby reference as part of the present disclosure: U.S. patent applicationSer. No. 10/640,500, filed Aug. 13, 2003, entitled “Container And ValveAssembly For Storing And Dispensing Substances, And Related Method,”U.S. patent application Ser. No. 29/174,939, filed Jan. 27, 2003,entitled “Container and Valve Assembly,” U.S. patent application Ser.No. 29/188,310, filed Aug. 15, 2003, entitled “Tube and Valve Assembly,”U.S. patent application Ser. No. 29/191,510, filed Oct. 7, 2003,entitled “Container and Valve Assembly,” U.S. Patent Application Ser.No. 60/528,429, filed Dec. 10, 2003, entitled “Valve Assembly And TubeKit For Storing And Dispensing Substances, And Related Method,” and U.S.Patent Application Ser. No. 60/539,602, filed Jan. 27, 2004, entitled“Tubular Container And One-Way Valve Assembly For Storing And DispensingSubstances, And Related Method.”

In FIGS. 5-7, another dispenser embodying the present invention isindicated generally by the reference numeral 110. The dispenser 110 issubstantially similar to the dispenser 10 described above with referenceto FIGS. 1-4, and therefore like reference numerals preceded by thenumeral “1” are used to indicate like elements. A primary difference ofthe dispenser 110 in comparison to the dispenser 10 described above isin the shape and configuration of the piston 134 and bore 118. As can beseen, the bore 118 is not substantially cylindrical as described above,but rather is defined by a substantially concave recess. Similarly, thepiston 134 is defined by the underside of the dome-shaped actuator 132.Accordingly, as shown typically in FIGS. 6 and 7, when a user manuallydepresses the dome-shaped actuator 132, the underside 134 thereoffunctions as a piston and, in turn, pressurizes the substance within thecompression chamber 138 and forces same through the one-way valve 124.Accordingly, in the rest or ambient position, as shown typically in FIG.5, the underside 134 of the manually-engageable actuator 132 is spacedaway from the stop surface 140 and defines a substantially concave shapeas shown. Then, as shown typically in FIGS. 6 and 7, in order todispense a metered dose, the actuator 132 is manually depressed untilthe underside 134 is located adjacent to, or in contact with the stopsurface 140 at the base of the substantially concave bore 118. In thefully-actuated position, and as shown typically in FIG. 7, the centralportion of the actuator 132 is substantially inverted.

The actuator and piston assembly 122 also includes an anti-reflux valve145 to prevent substance within the compression chamber 138 from flowingback into the variable-volume storage chamber 114 after depressing theactuator. As can be seen, the anti-reflux valve 145 is defined by alaterally projecting lobe 147 formed on the opposite side of the pistonor underside 134 relative to the one-way valve 124, and a correspondingrecess 149 formed in the body 112 at the junction of the bore 118 andfluid-passageway 142. As can be seen, as the actuator 132 is manuallydepressed, the lobe or flexible valve member 147 of the anti-refluxvalve 145 is received within the recess or valve seat 149 to seal thecompression chamber 138 with respect to the variable-volume storagechamber 114, and thereby prevent any substance from flowing in thedirection from the compression chamber 138 back into the variable-volumestorage chamber 114 during the compression stroke of the actuator. Acurvilinear buffer spring 151 is formed opposite the lobe 147 and spacedaxially between the lobe and flange 170 to allow the dome spring 144 toelongate itself during the compression stroke of the actuator andfacilitate the return of the dome spring from the fully-actuatedposition (FIG. 7) to the rest or ambient position (FIG. 5).

When the user releases the actuator 132, the substantially dome-shapedspring portion 144 thereof drives the actuator 132 and underside 134thereof into the ambient or rest position, as shown typically in FIG. 5.In the rest or ambient position of FIG. 5, the substance in thevariable-volume storage chamber 114 is drawn through the tapered channel151 and passageway 142 and into the compression chamber 138 to fill thecompression chamber for the next dose.

Another difference of the dispenser 110 in comparison to the dispenser10 is that the valve cover 128 and corresponding surface of the valveseat 126 define a substantially sigmoidal surface contour at the valveseam 130 in order to facilitate forming a reduced cross-sectionalthickness of the valve cover 128 at the dispensing tip and to direct thedispensed substance toward the central region of the applicator surface146.

In a currently preferred embodiment of the present invention, theactuator 32, 132 may be formed of a needle penetrable and resealablematerial in order to allow the dispenser 110 to be needle filled withthe substance to be stored therein, and resealed, in accordance with theteachings of the co-pending patents and patent applications incorporatedby reference below. During filling, it may be desirable to insert thefilling needle through a central portion of the dome-shaped actuator132, and to then slightly withdraw the needle prior to or duringfilling, in order to substantially maintain the concave or dome shape ofthe actuator, and to maintain the anti-reflux valve 145 open, duringfilling. Alternatively, the plunger 148 (not shown) may include a needlepenetrable and resealable stopper or like portion that permits thevariable-volume storage chamber 114 to be needle filled with a substancetherethrough, and that allows the resulting needle hole to be thermallyresealed, such as by application of laser energy thereto. Accordingly,the needle penetrable and resealable portion of the actuator and pistonassembly, the valve cover and actuator and piston assembly, and/or theplunger or resealable stopper or like portion thereof, may be formedwith any of the various materials disclosed in, and may be needle filledand resealed in accordance with the various teachings of, the followingpatents and co-pending patent applications that are assigned to theAssignee of the present invention and are hereby expressly incorporatedby reference as part of the present disclosure: U.S. Pat. No. 6,604,561,entitled “Medicament Vial Having a Heat-Sealable Cap, and Apparatus andMethod for Filling the Vial”; U.S. Pat. No. 6,684,916, entitled“Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Methodfor Filling the Vial”; U.S. patent application Ser. No. 10/694,364,filed Oct. 27, 2003, entitled “Medicament Vial Having a Heat-SealableCap, and Apparatus and Method for Filling the Vial”; U.S. patentapplication Ser. No. 10/766,172, filed Jan. 28, 2004, entitled“Medicament Vial Having a Heat-Sealable Cap, and Apparatus and Methodfor Filling the Vial”; U.S. patent application Ser. No. 10/600,525,filed Jun. 19, 2003, entitled “Sterile Filling Machine Having NeedleFilling within E-Beam Chamber”; U.S. patent application Ser. No.10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers and Methodsof Making and Filling Same”; U.S. provisional patent application Ser.No. 60/518,685, filed Nov. 10, 2003, entitled “Needle Filling and LaserSealing Station”; and U.S. patent application Ser. No. 11/070,440, filedMar. 2, 2005, entitled “Apparatus for Needle Filling and LaserResealing”.

FIGS. 8-9 illustrate another dispenser embodying the present inventionand indicated generally by the reference numeral 210. The dispenser 210is substantially similar to the dispenser 10 described above withreference to FIGS. 1-7, and therefore like reference numerals precededby the numeral “2” are used to indicate like elements.

The dispenser 210 includes a body 212 defining a variable-volume storagechamber 214 for storing a fluid or other substance, such as apharmaceutical, cosmeceutical, cosmetic, or ophthalmic product. Adispensing nozzle or portion 216 is connected with the body 212 anddefines a bore 218 coupled in fluid communication with the storagechamber 214 for receiving the stored substance therefrom, and at leastone outlet aperture 220 coupled in fluid communication with the bore218. An actuator and piston assembly 222 is receivable within the bore218, and a dispensing nozzle or one-way valve 224 is mounted on thedispensing portion 216 for dispensing metered amounts of the storedsubstance therethrough. A fluid passageway 242 extends between thepiston tip 236 and the inlet to the bore 218 and, when the piston 234 islocated in the rest position, as shown in typically FIG. 9, the fluidpassageway 242 is coupled in fluid communication between the dosagechamber 238 and storage chamber 214 for permitting the flow of fluid orother substance from the storage chamber into the dosage chamber.

The one-way valve 224 includes an axially-extending valve seat 226, andan axially-extending flexible valve cover 228 seated on the valve seatand defining a normally-closed, axially-extending seam 230 therebetweenforming a fluid-tight seal between the valve cover 228 and valve seat226. As described further below, the flexible valve cover 228 is movablerelative to the valve seat 226, and the seam 230 is connectable in fluidcommunication with the outlet aperture 220 to allow the passage ofproduct through the seam and out of the dispenser.

The dispensing nozzle 216 includes a tip portion 231 configured toprovide a substantially consistent dosage volume (or size) that isreleased into a user's eyes throughout usage of the dispenser. As shownin FIGS. 8 and 9, the end face 233 of the valve seat 226 is formed at anacute angle relative to the axis of the one-way valve 224, and the axialend portion 229 of the valve cover 228 extends axially outwardly of theend face 233 of the valve seat. In an exemplary embodiment, the angle ofthe end face 233 is approximately 30°; however, as may be recognized bythose of ordinary skill in the pertinent art based on the teachingsherein, this angle may be changed as desired or otherwise required by aparticular application. The axially outermost point 235 of the valveseat 226 is coincident with the outlet opening 220 through which eachmetered dosage is released from the dispenser. Also at this location,the valve cover 228 forms a substantially pointed tip 231 that, as shownbest in FIG. 9, is pointed substantially radially inwardly.

One advantage of the pointed tip 231 is that it presents a substantiallyreduced surface area in contact with each metered dosage upon beingdispensed through the outlet aperture 220 which, in turn, reduces thesurface tension between the dosage and the tip, and thereby facilitatesrelease of substantially the entire metered dosage from the tip. Yetanother advantage of this configuration is that it substantiallyprevents, or at least substantially reduces the formation of dosageresidue at the tip. Yet another advantage is that the pointed tipconfiguration 231 in combination with the piston 234 and dosage chamber238 provides a predetermined, substantially consistent and repeatabledose volume (or size) that is released from the dispenser and into auser's eyes or other target region. Yet another advantage of theillustrated tip configuration is that the hoop stress of the valve cover228 is reduced at the region of the tip 231 (where the valve cover isnot fully annular) which, in turn, reduces the velocity of the fluiddispensed through the valve 224. This, in combination with the radiallycurved nature of the tip 231 substantially prevents the dosage frombeing released in a spray, but rather facilitates in allowing the dropto be released from the pointed tip 231 in drop form. Still anotheradvantage of the illustrated tip configuration is that the pointed tip231 is pointed substantially radially inwardly, thereby presenting arounded, and substantially blunt tip to the user's eyes or other targetregion, while simultaneously providing a pointed surface region on theradial inner side of the rounded tip that facilitates in releasingsubstantially the entire metered dosage on a consistent and repeatablebasis. Yet another advantage of the illustrated dispenser is that eachdose is released at substantially the same location (i.e., from thepointed tip 231) thus allowing a user to consistently hold the dispenserin the same orientation, and accurately deliver the drops to the eyes orother target region in a repeatable manner.

The actuator and piston assembly 222 includes a manually engageableactuator 232, and a piston 234 formed integral with the actuator 232 formoving the piston within the bore 218 and dispensing a predeterminedamount of product within the bore through the outlet aperture 220 andone-way valve 224. The piston 234 is movable between a first or restposition, as shown in FIG. 9, with the piston tip 236 spaced away fromthe outlet aperture 220 and defining a compression chamber 238therebetween that is coupled in fluid communication with thevariable-volume storage chamber 214 through the fluid passageway 242,and a second fully-activated position (not shown, however, see FIG. 2)with the piston tip 236 located adjacent to, or in contact with a stopsurface 240 formed at the downstream end of the bore 218 for dispensinga predetermined amount of substance within the compression chamberthrough the outlet aperture 220. As can be seen, the actuator and pistonassembly 222 is formed integral with the valve cover 228. In theillustrated embodiment of the present invention, the actuator and pistonassembly 222 is molded into one piece with the valve cover 228. As alsoshown, the actuator 232 is laterally positioned with respect to theone-way valve 224. In the illustrated embodiment of the presentinvention, the piston drive axis is oriented at about 90° relative tothe axis of the one-way valve and body. However, as indicated above,this angle may be changed as desired or as may be required by aparticular application. The dispenser 210 operates in a similar mannerand is made of the same or similar materials as the dispenser 10, asdescribed above.

The dispenser 210 further includes a piston or plunger 248 that isslidably received within the body 212 and axially spaced relative to theactuator and piston assembly 222 to define the variable-volume storagechamber 214 therebetween. The plunger 248 includes an annular sealingmember 250 that engages the inner wall 252 in at least one andpreferably two axially-spaced locations. The sealing member 250sealingly engages the inner wall 252 of the body 212 to form afluid-tight seal therebetween. The plunger 248 also includes are-sealable stopper or portion 251 that is needle penetrable to fill thevariable-volume storage chamber 214 and is laser re-sealable tohermetically seal the resulting needle hole, as described further below.

The dispenser 210 further comprises an approximately annular securingmember 258 that is relatively rigid in comparison to the valve cover toprevent the valve cover 228 from expanding radially where the securingmember overlies the valve cover. In addition, the securing member 258prevents the valve cover 228 from being removed, and otherwise preventsthe hermetic seal between valve cover and body from being tampered with.In one embodiment of the dispenser 210, the valve cover 228 and securingmember 258 are formed by over molding, and the sealing member 250 andresealable stopper 251 of the plunger likewise are formed by overmolding. More particularly, in one embodiment of the present invention,the securing member 258 is injection molded in a first mold cavity.Then, the securing member 258 is robotically transferred to a secondmold cavity, and the valve cover 228 is injection over molded over thesecuring member in the second mold cavity. If desired, the valve covermay be over molded to the securing member in the same mold (or viceversa) to avoid the need to robotically or otherwise transfer a partfrom one mold to another prior to over molding. Similarly, the sealingmember 250 is molded in a first mold cavity, and a second mold insert orcavity is then employed in the same mold to over mold the resealablestopper 251 to the respective sealing member and thereby form theplunger 248. Preferably, each mold includes multiple mold cavities forsimultaneously molding and over molding multiple parts. In oneembodiment of the present invention, the body 212 forming thevariable-volume storage chamber 214 and relatively rigid valve seat 226is injection molded at substantially the same time as the over moldedsecuring member 258 and valve cover 228, and the plunger 248. Then, theover molded securing member and valve cover are robotically assembled tothe valve seat 226 end of the body 212 while at least part of the bodyis located in its respective mold and preferably at bactericidaltemperature (i.e., a temperature that is sufficiently high to kill anygerms thereon), and the plunger 248 is robotically assembled to theother end of the body 212 while at least part of the body is located inits respective mold and preferably at bactericidal temperature. Themolding and assembly is preferably performed under a substantiallylaminar flow of filtered sterile air or other gas to maintain asepticconditions. This type of molding and assembly process is described infurther detail in U.S. patent application Ser. No. 60/660,935, filedMar. 11, 2005, entitled “Apparatus and Method for Aseptically Moldingand Assembling Containers with Heated Surfaces, and Filling Same,” whichis assigned to the Assignee of the present invention and is herebyexpressly incorporated by reference as part of the present disclosure.

Alternatively, the body 212, over molded securing member 258 and valvecover 228, and plunger 248 may be molded in separate injection moldingmachines, the parts then may be assembled robotically or otherwise in acommercially clean environment, and the assembled, sealed emptydispensers then may be sterilized, such as by the application ofradiation thereto, including for example gamma radiation, and thenneedle filled and laser resealed in the manner generally described inthe patent and patent applications incorporated by reference above.

In the illustrated embodiment, the sealing member 250 is made of arelatively resilient plastic material, such as one of the plastics soldunder the trademark Santoprene™ (e.g., Santoprene 8211-35 (shore 35hardness) or 8211-55 (shore 55 hardness)). As may be recognized by thoseof ordinary skill in the pertinent art based on the teachings herein,these materials are only exemplary, and may be changed as desired orotherwise required by a particular application. For example, inapplications requiring low sorption, the sealing member 150 anddispenser body 112 may be formed of a relatively low sorptive material,such as a relatively hard plastic, including one or more of the plasticssold under the trademark Topaz™.

In addition, the re-sealable stopper 251 is formed of a thermoplasticmaterial defining a needle penetration region that is pierceable with aneedle to form a needle aperture therethrough, and is heat re-sealableto hermetically seal the needle aperture by applying laser radiation ata predetermined wavelength and power thereto. The stopper 251 includes athermoplastic body defining (i) a predetermined wall thickness in anaxial direction thereof, (ii) a predetermined color and opacity thatsubstantially absorbs the laser radiation at the predeterminedwavelength and substantially prevents the passage of the radiationthrough the predetermined wall thickness thereof, and (iii) apredetermined color and opacity that causes the laser radiation at thepredetermined wavelength and power to hermetically seal the needleaperture formed in the needle penetration region thereof in apredetermined time period and substantially without burning the needlepenetration region (i.e., without creating an irreversible change inmolecular structure or chemical properties of the material). In someembodiments, the predetermined time period is approximately 2 seconds,is preferably less than or equal to about 1.5 seconds, and mostpreferably is less than or equal to about 1 second. In some of theseembodiments, the predetermined wavelength of the laser radiation isabout 980 nm, and the predetermined power of each laser is less thanabout 30 Watts, and preferably less than or equal to about 10 Watts, orwithin the range of about 8 to about 10 Watts. Also in some of theseembodiments, the predetermined color of the material is gray, and thepredetermined opacity is defined by a dark gray colorant (or pigment)added to the stopper material in an amount within the range of about0.3% to about 0.6% by weight.

In addition to the thermoplastic materials described above, thethermoplastic material of the stopper 251 may be a blend of a firstmaterial that is preferably a styrene block copolymer, such as thematerials sold under either the trademarks KRATON or DYNAFLEX, such asDYNAFLEX G2706-10000-00, or GLS 230-174 (Shore A=30), and a secondmaterial that is preferably an olefin, such as the materials sold undereither the trademarks ENGAGE or EXACT, such as EXACT 8203, or GLS230-176 (Shore A=42). In some embodiments, the first and secondmaterials are blended within the range of about 50:50 by weight topreferably about 90:10 by weight, and most preferably about 90:5 byweight (i.e., first material:second material). The benefits of thepreferred blend over the first material by itself are improved water orvapor barrier properties, and thus improved product shelf life; improvedheat sealability; a reduced coefficient of friction; improvedmoldability or mold flow rates (which is discussed below); and areduction in hysteresis losses.

Alternatively, the thermoplastic material of the re-sealable stoppers251 may take the form of a styrene block copolymer sold by GLSCorporation of McHenry, Ill. under the designation LC 254-071. This typeof styrene block copolymer compound exhibits approximately the followingphysical properties: (i) Shore A Hardness: about 28-29; (ii) SpecificGravity: about 0.89 g/cm³; (iii) Color: approximately grey to dark grey;(iv) 300% Modulus, flow direction: about 181-211 psi; (v) TensileStrength at Break, flow direction: about 429-498 psi; (vi) Elongation atBreak, flow direction: about 675%-708%; and (vii) Tear Strength, flowdirection: about 78-81 lbf/in.

In each of these embodiments of the present invention, the predeterminedcolor and opacity of the thermoplastic is defined by a grey colorantthat is provided in an approximately 3% color concentrate (i.e., thereis an approximately 33:1 ratio of the concentrate to the natural resinor TPE). The color concentrate contains about 88.83% carrier or baseresin, the remainder is pigment, and the pigment is grey carbon black.Thus, the pigment is about 0.34% by weight of the resultingthermoplastic.

In addition, if desired, a lubricant of a type known to those ofordinary skill in the pertinent art may be added to or included withineach of the above-mentioned thermoplastic compounds, in order to preventor otherwise reduce the formation of particles upon penetrating theneedle penetration region of the thermoplastic stopper with a needle orother filling member. In one embodiment of the present invention, thelubricant is a mineral oil that is added to the styrene block copolymeror other thermoplastic compound in an amount sufficient to prevent, orsubstantially prevent, the formation of particles upon penetrating samewith the needle or other filling member. In another embodiment, thelubricant is a silicone, such as the liquid silicone sold by Dow CorningCorporation under the designation “360 Medical Fluid, 350 CST,” or asilicone oil, that is added to the styrene block copolymer or otherthermoplastic compound in an amount sufficient to prevent, orsubstantially prevent, the formation of particles upon penetrating samewith the needle or other filling member. In one such embodiment, thesilicone oil is included in an amount within the range of about 0.4% toabout 1% by weight, and preferably within the range of about 0.4 toabout 0.6% by weight, and most preferably within the range of about 0.51or about 0.5% by weight.

Alternatively, the resealable stopper or like portions of the dispensermay be made with one or more of the materials disclosed in internationalPCT patent application no. PCT/EP2004/008703, (WO2005/014419 A1), filedAug. 2, 2004, which claims priority to Great Britain patent applicationno. 031824.25, filed Aug. 4, 2003, each of which is hereby incorporatedby reference as part of the present disclosure.

After needle filling the storage chamber 214 through, and laserresealing the stopper 251 of the plunger 248, a cap 253 is fixedlysecured to the open end of the body 212 to prevent access to theinterior of the body. The cap 253 includes one or more vent apertures(not shown) to prevent the formation of a vacuum between the plunger 248and cap 253, and otherwise to allow the plunger 248 to freely travelthrough the body 212 upon dispensing the substance from the storagechamber 214.

FIGS. 10 and 11 illustrate another dispenser embodying the presentinvention and indicated generally by the reference numeral 310. Thedispenser 310 is substantially similar to the dispenser 210 describedabove with reference to FIGS. 1-9, and therefore like reference numeralspreceded by the numeral “3” are used to indicate like elements. Inparticular, the main difference between dispenser 310 and dispenser 210is that the piston 334 is angled as compared to the piston 234 (in FIG.9). As shown, the piston 334 is angled approximately 20° relative to anormal to the axis of the body 312. The piston 334 is angled to assistin the molding of the valve cover 328. The angle can range fromapproximately 10° to approximately 40°, and most preferably fromapproximately 20° to approximately 30°. In this embodiment, the tip 331of the dispenser is shaped to be more pointed rather than rounded. Ascan be seen, the axially outermost portion 331 extends axially outwardlyrelative to the adjacent surface 335 of the valve seat 326, but does notcurve radially inwardly as in the dispenser 210 of FIGS. 8 and 9. Aswith the dispenser 210 above, the axially-extending tip 331 is designedto facilitate release of the drop and to prevent the drop from rollingback onto the valve face 333. It is noted that any shape thatfacilitates the release of the drop, a reduction in drop residue on thetip, and a consistent and repeatable dosage volume (or size) that isreleased into the eye, is contemplated.

FIGS. 12 and 13 illustrate another dispenser embodying the presentinvention and indicated generally by the reference numeral 410. Thedispenser 410 is substantially similar to the dispensers 10, 110, 210,and 310 described above with reference to FIGS. 1-11, and therefore likereference numerals preceded by the numeral “4” are used to indicate likeelements.

The primary difference of the dispenser 410 in comparison to thedispensers described above is that the entire end 433 of the dispensingnozzle is rounded and has an opening 439 for dispensing metered drops ordosages therethrough. In addition, the piston tip 436 is shaped tofacilitate the formation of a fluid-tight seal between the tip of thepiston 434 and the bore 418 and to, in turn, facilitate in dispensingthe metered dosages of substance through the outlet aperture 420.Exemplary materials for the actuator 432 includes Rimflex A/AS 25C andDynaflex G2706, for the securing member 458 includes Alathon H5112 andProfax SR 549, for the annular sealing member 450 includes HuntsmanLDPE2053 and Bormed LE6603-PH, and for the body 412 includes Zeonor 750R(COC), Eastar EN067 (PET), and Barex 210 (Acrylic). These materials areequally applicable for any of the embodiments of the dispensersdisclosed herein. As will be recognized by those of ordinary skill inthe pertinent art based on the teachings herein, however, thesematerials are only exemplary, and numerous other materials that arecurrently known, or that later become known, equally may be employed. Aswith the embodiment illustrated in FIG. 9, the dispenser 410 or selectcomponents or subassemblies thereof can be formed through molding andovermolding processes as described above. The dispenser 410 isparticularly suited for delivering metered dosages to the eye or ear,but alternatively may be used to deliver metered dosages to any of avariety of other target areas, such as for oral, nasal, vaginal or analdelivery.

In FIG. 14, another dispenser embodying the present invention isindicated generally by the reference numeral 510. The dispenser 510 issubstantially similar to the dispenser 10 described above, and thereforelike reference numerals preceded by the numeral “5” are used to indicatelike elements. The dispenser 510 is particularly suited for deliveringophthalmic substances, such as eye drops. The primary difference of thedispenser 510 in comparison to the dispensers disclosed above is theconfiguration of the dispensing nozzle 516. As can be seen, the axialend portion 529 of the valve cover 528 extends radially inwardly overthe axial end face 533 of the valve seat 526, and covers a substantialportion of the axial end face. In the illustrated embodiment, the axialend portion 529 of the valve cover 526 covers about one-half of thesurface area of the axial end face 533 and extends axially outwardlyrelative to the other portions of the valve cover and valve seat tothereby present a substantially rounded, blunt dispensing tip. Thedispensing aperture 520 is aligned with the axial end portion 535 of thevalve seat 526 and dispensing tip 531 of the valve cover 528 to dispensethe metered dosages of substance therethrough. As can be seen, and inthe same manner or similar to that of the dispensing tips 231 and 331described above, the tip 531 defines a dispensing region or point ofsubstantially reduced surface area for facilitating the release ofmetered dosages of substance therefrom, and to prevent dosage residuefrom collecting thereon. The relatively blunt and rounded axiallyoutermost point 529 of the valve cover 528, on the other hand, protectsthe eye or other target area from the pointed tip 531. As can be seen,the dispensing tip of the dispenser 510 is particularly suited fordelivered metered dosages of substances to a user's eye; however, aswith other dispensers disclosed herein, the dispenser 510 equally may beused to deliver metered dosages of substances to other target areas,such for delivery nasally, anally, vaginally, to the penis, or for oticdelivery.

In FIG. 15, another dispenser embodying the present invention isindicated generally by the reference numeral 610. The dispenser 610 issubstantially similar to the dispenser 10 described above, and thereforelike reference numerals preceded by the numeral “6” are used to indicatelike elements. The dispenser 610 is particularly suited for deliveringophthalmic substances, such as eye drops, but alternatively may be usedto deliver metered dosages to other target areas. The primary differenceof the dispenser 610 in comparison to the dispensers disclosed above isthe configuration of the dispensing tip 616. As can be seen, the endface 633 of the valve seat 626 extends axially outwardly of the valvecover 624, and defines a conical surface that terminates in aconically-pointed tip 635. The pointed tip 635 defines a dispensingsurface of reduced surface area to facilitate releasing the metereddosages and substance therefrom, and to prevent the collection of dosageresidue thereon. The dispensing tip 616 is further defined by theaxially outermost end portion 659 of the securing member 658 that formsa rounded, blunt dispensing tip that extends axially outwardly of, andradially over the conically pointed tip 635 to prevent the pointed tipfrom contacting a user's eye. The end portion 659 of the dispensing tip616 defines a dispensing aperture 661 that is aligned with the outletaperture 620 of the one-way valve 624 to permit the metered dosages ofsubstance released from the conically-pointed tip 635 to be dispensedtherethrough and directed onto the target area, such as a user's eye.

In FIG. 16, another dispenser embodying the present invention isindicated generally by the reference numeral 710. The dispenser 710 issubstantially similar to the dispenser 110 described above withreference to FIGS. 5-7, and therefore like reference numerals precededby the numeral “7” instead of the numeral “1” are used to indicate likeelements. The dispenser 710 is particularly suited for deliveringpharmaceutical, dermatological, cosmeceutical, and cosmetic substances,such as creams, gels, and other substances. The primary difference ofthe dispenser 710 in comparison to the dispensers disclosed above is theconfiguration of the dispensing tip 716. As can be seen, the securingmember 758 extends axially outwardly adjacent to the axially outermostend of the valve cover 728 to protect the valve cover and preventtampering therewith. In addition, as shown typically in FIG. 16, theoutlet aperture 720 may be defined by an axially-extending groove formedwithin the valve seat 726 to facilitate the flow of creams, gels orother relatively viscous substances therethrough, and to control thelocation at which the metered dosages are dispensed on or through theapplicator surface 746. Preferably, an annular space (not shown) isformed between the axially outermost end of the valve cover 728 and thesecuring member 758 to permit the valve cover to move radially outwardlytoward the adjacent wall of the securing member during dispensing ofdosages therethrough. In contrast to the embodiment of FIGS. 5-7, theanti-reflux valve 745 is formed by a lobe 747 extending radiallyupwardly from the opposite side of the valve cover 728 relative to theintegral actuator and piston 722, and to the rearward side of thecompression chamber 738. As may be recognized by those of ordinary skillin the pertinent art based on the teachings herein, although thecross-sectional thickness of the valve cover 728 is shown as increasingin thickness in the axial direction toward the dispensing tip, the valvecover equally may decrease in thickness as in the other embodimentsdisclosed herein, and/or the valve seat 726 may increase in diameter orwidth in the axial direction toward the dispensing tip, to facilitatethe dispensing of metered dosages outwardly through the one-way valveand prevent any ingress of substances in the opposite direction.

In FIG. 17, another dispenser embodying the present invention isindicated generally by the reference numeral 810. The dispenser 810 issubstantially similar to the dispenser 10 described above, and thereforelike reference numerals preceded by the numeral “8” are used to indicatelike elements. The dispenser 810 is particularly suited for deliveringsubstances to the ear (i.e., otic delivery) but alternatively may beused to deliver metered dosages to other target areas. The primarydifference of the dispenser 810 in comparison to the dispensersdisclosed above is the configuration of the dispensing tip 816. As canbe seen, the dispensing tip 816 is significantly elongated in comparisonto the other dispensing tips illustrated herein, and defines an axiallength at least several times greater than (e.g., at least about 3 to 5times greater than) its diameter or width. As also shown, the dispensingtip 816 tapers inwardly toward to the tip to facilitate insertion of thetip into an ear or other target cavity or region. If desired, and asshown in FIG. 17, the valve seat 826 may be formed in two parts, 826Aand 826B, that are fixedly secured to each other. In the illustratedembodiment, the first valve seat part 826A includes a male fasteningportion 827A, and the second valve seat part 826B includes a femalefastening portion 827B that receives the male fastening portion. Themale and female fastening portions 827A and 827B, respectively, may beinterconnected by a mechanical interlock, such as a snap engagementformed, for example, by a radially projecting male lobe(s) andcorresponding female recess(es), by welding, such as ultrasonic or spinwelding, adhesives, or any of numerous other connecting mechanisms thatare currently known or that later become known for performing thisfunction. The integral valve cover 828 and actuator 822 further definesa radially-projecting lobe 860 formed between the valve cover 828 andlateral actuator 822. As shown in FIG. 17, the portion of the lobeadjacent to, or located on the same side of the dispenser 810 as theactuator 822 extends radially outwardly to a greater extent than thediametrically opposed portion of the lobe. The lobe 860 may function asa finger stop, and also as a stop to prevent further insertion of thedispensing tip 816 into the ear or other target cavity or region. Oneadvantage of forming the valve seat 826 in two parts is that it enablesthe dispensers of the present invention to be manufactured to includeany of a variety of different types of dispensing tips whilenevertheless allowing such different dispensers to share commoncomponents, such as bodies, plungers, etc.

In FIG. 18, another dispenser embodying the present invention isindicated generally by the reference numeral 910. The dispenser 910 issubstantially similar to the dispenser 210 described above withreference to FIGS. 8 and 9, and therefore like reference numeralspreceded by the numeral “9” instead of the numeral “2” are used toindicate like elements. As with the dispenser 210 described above, thedispenser 910 is particularly suited for delivering substances to theeye, but alternatively may be used to deliver metered dosages to othertarget areas. The primary difference of the dispenser 910 in comparisonto the dispensers disclosed above is the configuration of the dispensingtip 916. As can be seen, the dispensing nozzle 916 includes a tipportion 931 configured to provide a substantially consistent dosagevolume (or size) that is released into a user's eyes or other targetregion throughout usage of the dispenser. The end face 933 of the valveseat 926 is recessed inwardly relative to the axial outermost portionsof the one-way valve 924, and the axial outermost point 925 of the valveseat tapers inwardly to a substantially pointed distal region defining avery narrow cross-sectional thickness. The axially outermost point 935of the valve seat 926 also is coincident with the outlet opening 920through which each metered dosage is released from the dispenser.Accordingly, the valve seat 926 defines a relatively small surface areaat the dispensing location of the metered dosages to thereby prevent theformation of dosage residue due to surface tension on the valve seatand, in turn, facilitate the provision of substantially consistentdosage volumes throughout usage of the dispenser. Also at the dispensinglocation, the valve cover 928 forms a substantially pointed tip 931 thatcurves radially outwardly from the outermost point 935 of the valveseat. Similar to the valve seat 925, the tip 931 of the valve cover 928tapers inwardly to a substantially pointed distal region defining a verynarrow cross-sectional thickness. As a result, the tip 931 of the valvecover 928 defines a relatively small surface area at the dispensinglocation of the metered dosages to thereby prevent the formation ofdosage residue due to surface tension on the valve tip and, in turn,facilitate the provision of substantially consistent dosage volumesthroughout usage of the dispenser.

Accordingly, the pointed tip 931 presents a substantially reducedsurface area in contact with each metered dosage upon being dispensedthrough the outlet aperture 920 which, in turn, reduces the surfacetension between the dosage and the tip, and thereby facilitates releaseof substantially the entire metered dosage from the tip. As a result,the tip configuration preferably substantially prevents, or at leastsubstantially reduces the formation of dosage residue at the tip. Yetanother advantage is that the pointed tip configuration in combinationwith the piston and dosage chamber provide a predetermined,substantially consistent and repeatable dose volume (or size) that isreleased from the dispenser and into a target region, such as an eye.Yet another advantage of the illustrated tip configuration is that thehoop stress of the valve cover 928 is reduced at the region of the tip931 (where the valve cover is not fully annular) which, in turn, reducesthe velocity of the fluid dispensed through the valve 924. This, incombination with the radially curved nature of the tip 931 substantiallyprevents the dosage from being released in a spray, but ratherfacilitates in allowing the dose to be released from the pointed tip 931in drop form and into a user's eye or other target region. Still anotheradvantage of the illustrated tip configuration is that the pointed tip931 is pointed substantially radially outwardly away from the axis ofthe dispenser, thereby presenting the rounded, and substantially blunttip 929 to the user's eye or other target region, while simultaneouslyproviding a pointed surface region on the radial outer side of the tipto facilitate releasing substantially the entire metered dosage on aconsistent and repeatable basis. Yet another advantage of theillustrated dispenser is that each dose is released at substantially thesame location (i.e., from the pointed tip 931) thus allowing a user toconsistently hold the dispenser in the same orientation, and accuratelydeliver the drops to the eyes or other target region in a repeatablemanner.

In FIG. 19, another dispenser embodying the present invention isindicated generally by the reference numeral 1010. The dispenser 1010 issubstantially similar to the dispensers described above with referenceto FIGS. 8 through 14, and therefore like reference numerals preceded bythe numeral “10” are used to indicate like elements. As with many of thedispensers described above, the dispenser 1010 is particularly suitedfor delivering substances to the eye, but alternatively may be used todeliver metered dosages to other target areas, such as the ear. Aprimary difference of the dispenser 1010 in comparison to the dispensersdisclosed above is the configuration of the dispensing tip 1016. As canbe seen, the valve seat 1026 defines an angled end face 1033, asubstantially thicker valve cover portion 1029 located diametricallyopposite the dispensing location 1035 of the valve seat, and asubstantially thinner valve cover portion 1031 located at the dispensinglocation 1035 of the valve seat. As shown in FIG. 19, the upper regionof the valve cover 1028 in the drawing both progressively expandsradially outwardly and progressively tapers radially inwardly in thedirection toward the axially-outermost point 1029, and the upper regionof the valve seat 1026 in the drawing tapers radially inwardly in thedirection toward the axially-outermost point of the valve seat, tothereby progressively increase the hoop stress in the valve cover 1028when moving through the valve cover axially outwardly in this thickenedregion of the valve cover. On the diametrically opposite side of thevalve cover 1028 (or the lower portion of the valve cover in thedrawing), on the other hand, the valve cover tapers radially inwardlytoward the axially-outermost point or dispensing location 1035, and thevalve seat 1026 neither tapers inwardly or outwardly in this region. Asa result, the hoop stress in the valve cover 1028 is substantiallyreduced at and near the dispensing location 1035 in comparison to theother regions of the valve cover to thereby consistently direct themetered dosages through the one-way valve 1024 at the dispensinglocation throughout usage of the dispenser. The tapered and pointedconfiguration 1031 of the valve cover 1026 also reduces the surface areaof the valve cover at the dispensing location 1035 to facilitatereleasing substantially the entire metered dosage and substantiallypreventing the formation of dosage residue and thereby, in turn,providing a substantially consistent dosage volume and dispensinglocation on the dispensing tip throughout usage of the dispenser. Ifdesired, the valve seat 1026 may define a recessed end face 1033 asshown in FIG. 18, for example, to further reduce the surface area andthus the surface tension at the dispensing location 1035.

In FIG. 20, another dispenser embodying the present invention isindicated generally by the reference numeral 1110. The dispenser 1110 issubstantially similar to the dispenser 1010 described above withreference to FIG. 19, and therefore like reference numerals preceded bythe numeral “11” instead of the numeral “10” are used to indicate likeelements. As with many of the dispensers described above, the dispenser1010 is particularly suited for delivering substances to the eye, butalternatively may be used to deliver metered dosages to other targetareas, such as the ear. The primary difference of the dispenser 1110 incomparison to the dispensers disclosed above is the configuration of thedispensing tip 1116. As can be seen, the end face 1133 of the valve seat1126 extends axially outwardly a distance “D” relative to the valvecover 1128 at the dispensing location 1135. As with the dispenser ofFIG. 19 described above, the valve cover 1128 is thicker in the regionlocated diametrically opposite the dispensing location 1135 to preventthe passage of metered dosages through this region, and direct thedosages instead toward the dispensing location 1135. Similarly, on thediametrically opposite side of the valve cover 1128 (or the lowerportion of the valve cover in the drawing), the valve cover 1128 tapersradially inwardly toward the axially-outermost point or dispensinglocation 1135 such that it is progressively thinner than thediametrically opposite portion of the valve cover. The securing member1158 includes an axial extension 1159 that overlies the thicker regionsof the valve cover 1128, but not the tapered region leading into andlocated at the dispensing location 1135. The securing member 1158, andin particular, the axial extension 1159 thereof, engages the outersurface of the valve cover 1128 to thereby substantially prevent thevalve cover from expanding radially outwardly. If desired, the securingmember 1158, and/or the axial extension 1159 thereof, may form aninterference fit with the valve cover to further prevent such radialexpansion of the valve cover. As a result, the hoop stress in the valvecover 1128 is substantially reduced in the tapered region at and nearthe dispensing location 1135 in comparison to the other regions of thevalve cover to thereby consistently direct the metered dosages throughthe one-way valve 1124 at the dispensing location 1135 throughout usageof the dispenser.

In a currently preferred embodiment of the present invention forophthalmic applications, the distance “D” to which the valve seat 1126extends axially outwardly of the valve cover 1128, and the shape of thevalve seat in this region, are selected based on the physicalcharacteristics of the liquid dispensed, to achieve release of eachmetered dosage in a substantially single drop of substantiallypredetermined volume. If desired, the type of material employed for thevalve seat 1126 or the tip portion thereof also may be selected toinfluence this goal (including, for example, the degree to which thematerial or its surfaces are hydrophobic or hydrophilic, or thecoefficient of friction of such surfaces). In one such embodiment, thepredetermined volume of each metered drop is within the range of about15 to about 30 microliters, and most preferably within the range ofabout 18 to about 25 microliters. In one such embodiment, thepredetermined volume is at least about 20 microliters. Accordingly, thedistance “D” and shape of the release surface 1135 (and thus the surfacearea that contacts each metered dose) is selected to create sufficientsurface tension for the predetermined substance being dispensed tocreate thereon a substantially single drop of substantiallypredetermined volume, yet not so much surface tension as to preventrelease of the drop of predetermined volume therefrom. The tapered andpointed configuration 1131 of the valve cover 1126 also reduces thesurface area of the valve cover at the dispensing location 1135 tofacilitate releasing substantially the entire metered dosage andsubstantially preventing the formation of dosage residue, and thereby inturn providing a substantially consistent dosage volume and dispensinglocation on the dispensing tip throughout usage of the dispenser.

The bore 1118 defines one or more slots 1119 formed in the side wallthereof at the inlet to the bore to thereby define the volume of thecompression zone 1138 located below the slots within the bore, and thusthe volume of each metered dosage dispensed. The slots 1119 alsofacilitate the return of the actuator and piston assembly 1122 to itsrest position as shown in FIG. 20 by reducing the back pressure on thepiston when located nearest its rest position and in the region in whichthe spring force of the dome spring is lowest.

In FIGS. 21 through 23 another dispenser embodying the present inventionis indicated generally by the reference numeral 1210. The dispenser 1210is substantially similar to the dispenser 1110 described above withreference to FIG. 20, and therefore like reference numerals preceded bythe numeral “12” instead of the numeral “11” are used to indicate likeelements. As with many of the dispensers described above, the dispenser1210 is particularly suited for delivering substances to the eye, butalternatively may be used to deliver metered dosages to other targetareas, such as the ear. The primary difference of the dispenser 1210 incomparison to the dispenser 1110 described above, is that the dispenser1210 defines a substantially symmetrical valve cover 1228 at thedispensing tip. In addition, as shown in FIG. 22, the valve cover 1228defines on its inner surface at the interface between the valve coverand valve seat a plurality of raised surface areas 1229 that are axiallyspaced relative to each other and corresponding recessed surface areaslocated between the raised surface areas. The raised surface areas 1229project radially inwardly to a greater extent than do the correspondingrecessed surface areas and the other inner surfaces of the valve cover,and thus form a greater degree of interference between the valve coverand valve seat in comparison to the other surfaces of the valve cover.In the illustrated embodiment, the raised surface areas 1229 defineapproximately twice the level of interference between such surface areasand the valve seat in comparison to the other inner surfaces of thevalve cover. However, as may be recognized by those of ordinary skill inthe pertinent art based on the teachings herein, this differentialdegree of interference may be changed as desired or otherwise requiredby a particular application, and may be, for example, within the rangeof about 1.5 to 2.5 times greater than the interference of adjacentvalve cover surfaces. As can be seen, the raised surface areas 1229 arenot annular, but rather extend through only a portion of the annularinterface between the valve cover and the valve seat. In the illustratedembodiment, the raised surface areas extend throughout approximately270° of the annular interface between the valve cover and valve seat,and preferably extend throughout a portion of the interface within therange of about 250° to about 290° of the annular interface. However, asmay be recognized by those of ordinary skill in the pertinent art basedon the teachings herein, these numbers may be changed as desired orotherwise required by a particular application.

One advantage of the raised surface areas is that they enhance the sealbetween the valve cover and valve seat without over-compressing thevalve (i.e., without creating too high a valve-opening pressure). Inaddition, if the interference between the valve cover and valve seat istoo high, the valve cover may bulge or otherwise become distorted incertain areas. Accordingly, the raised surface areas allow theinterference between the valve cover and valve seat to be reduced incomparison to what otherwise might be required to maintain the integrityof the valve seal throughout shelf-life and usage of the dispenser, andthus may allow for a corresponding decrease in the valve-openingpressure. In addition, the raised surface areas facilitate in directingthe valve flow through the angular extent of the interface that does notinclude the raised surface areas (i.e., the 90° portion located betweenthe opposing ends of the raised surface areas). As can be seen, theangular extent between the ends of the raised surface areas is alignedwith the dispensing location 1235 to facilitate directing the metereddosages thereto.

As shown in FIG. 21, the bore 1218 defines at its inlet an expandedannular portion or ring 1219 rather than the slots described above tothereby define the volume of the compression zone 1238 located below theannular ring 1219 within the bore, and thus the volume of each metereddosage dispensed. As with the slots described above, the annular ring1219 facilitates the return of the actuator and piston assembly 1222 toits rest position as shown in FIG. 21 by reducing the back pressure onthe piston when located nearest its rest position and in the region inwhich the spring force of the dome spring is lowest. As also shown inFIG. 21, the piston 1234 defines an approximately conically-pointed tipfacing the stop surface 1240 of the bore to facilitate the action of thepiston within the bore. As also shown typically in FIG. 21, the body1212 may define a plurality of recessed surface areas or keys 1213, withcorresponding raised surface areas located therebetween (not shown) tofacilitate engaging the body in an assembly fixture as needed to alignthe body with the valve cover and/or for securing the components priorto and/or during assembly thereof.

Turning to FIG. 23, the dispensers may include a modified plunger 1248′,particular for use in connection with applications employing a needlepenetrable and laser re-sealable stopper 1251′ as described above. Inthe illustrated embodiment, the needle penetrable and laser re-sealablestopper is over-molded to an axially-extending flange 1253′ of thesealing member 1250′. As can be seen, the re-sealable stopper 1251′defines an axially-exposed face 1255′ that is directed towards the backend of the body 1212. The face 1255′ is adapted to engage a fixture (notshown) for securing the position of the plunger 1248′ during needlefilling through the stopper 1251′. In one such embodiment, the fixtureengages the face 1255′ and includes vacuum ports coupled in fluidcommunication with the face to secure the face to the fixture, andthereby secure the plunger to the fixture during needle penetration andfilling through the stopper. As may be recognized by those of ordinaryskill in the pertinent art based on the teachings herein, the shapeand/or other physical features of the stopper and/or other aspects ofthe plunger may be changed as desired or otherwise required to allow theplunger to engage a needle filling fixture and thereby secure theposition of the plunger during needle penetration and fillingtherethrough.

As may be recognized by those of ordinary skill in the pertinent artbased on the teachings herein, numerous changes and modifications may bemade to the above-described and other embodiments of the presentinvention without departing from the spirit of the invention as definedin the claims. For example, the components of the dispensers may be madeof any of numerous different materials that are currently known, or thatlater become known for performing the function(s) of each suchcomponent. Similarly, the components of the dispensers may take any ofnumerous different shapes and/or configurations. Also, the dispensersmay be used to dispense any of numerous different types of fluids orother substances for any of numerous different applications, including,for example, cosmetic, dermatological, ophthalmic or otherpharmaceutical, cosmeceutical and/or OTC applications. In addition, thecharacteristics of the dispensers may be adjusted, including for examplethe shape and/or configuration of the dispensing tip, the volume of themetered dosages, and/or the valve opening pressure, to meet therequirements of any of numerous different applications and/or productsto be dispensed, including without limitation products that aredelivered topically, such as to the skin or to mucous membranes,products that are delivered to the ear (i.e., otic delivery), to thepenis, nasally, vaginally, anally or orally. Further, the fillingmachines used to fill the dispensers of the present invention may takeany of numerous different configurations that are currently known, orthat later become known for filling the dispensers. For example, thefilling machines may have any of numerous different mechanisms forsterilizing, feeding, evacuating and/or filling the dispensers. Ifdesired, the surface contour of the valve seat may be adjusted tofacilitate directing the valve-flow through a predetermined dispensinglocation at the valve tip. For example, the annular surface of the valveseat may define different angular segments, wherein the differentangular segments are defined by different radii. In one such embodiment,the lower valve seat radii are provided in those areas where it isdesired to achieve a higher stress concentration between the valve coverand valve seat, and thereby prevent or otherwise reduce the valve flowtherethrough. The higher valve seat radii, on the other hand, areprovided in those where it is desired to achieve a lower stressconcentration between the valve cover and valve seat, and therebyenhance or otherwise increase the proportion of valve flow therethrough.In one such embodiment, the largest radius is aligned with thedispensing location, and the lowest radii are located on opposite sidesof such location relative to each other. In addition, rather than usethe needle penetrable and resealable actuator, plunger, or other likestopper, the dispenser may employ a filling valve as disclosed in thefollowing patent application that is assigned to the Assignee of thepresent invention, and is hereby incorporated by reference as part ofthe present disclosure: U.S. application Ser. No. 10/843,902, filed May12, 2004, titled “Dispenser and Apparatus and Method for Filling aDispenser”. In such alternative embodiments, the filling valve mayextend through the body or otherwise may be coupled in fluidcommunication with the storage chamber to evacuate and/or fill thestorage chamber. Alternatively, the dispenser may include one valve forevacuating the interior of the dispenser and another valve for fillingthe storage chamber of the dispenser. Still further, the piston and/ordispensing valve each may take a configuration that is different thanthat disclosed herein. Accordingly, this detailed description ofcurrently preferred embodiments is to be taken in an illustrative, asopposed to a limiting sense.

1. A dispenser for dispensing a substance, comprising: a body includinga variable-volume storage chamber for storing the substance; adispensing portion connected with the body and including a compressionchamber coupled in fluid communication with the storage chamber forreceiving substance therefrom, and an outlet aperture coupled in fluidcommunication with the compression chamber; a manually-engageableactuator mounted on the dispensing portion and including a manuallyengageable surface on an external side of the actuator and a compressionsurface on an internal side of the actuator, wherein the manuallyengageable surface is manually depressible between first and secondpositions to actuate the dispenser, and is normally biased in thedirection from the second position toward the first position; and aone-way valve forming an external portion of the dispenser including anaxially-extending valve seat and an axially-extending flexible valvecover seated on the valve seat and defining a normally-closed,axially-extending seam therebetween forming a fluid-tight seal betweenthe valve cover and valve seat, wherein the flexible valve cover ismovable relative to the valve seat and the seam is connectable in fluidcommunication with the outlet aperture to allow the passage of substancethrough the seam and out of the dispenser; wherein (i) during movementof the manually engageable surface in the direction from the secondposition toward the first position, the variable-volume storage chamberis in fluid communication with the compression chamber for permittingsubstance to flow from the variable-volume storage chamber into thecompression chamber, and (ii) during movement of the manually engageablesurface in the direction from the first position toward the secondposition (a) the compression chamber is not in fluid communication withthe variable-volume storage chamber and (b) the substance within thecompression chamber is pressurized above the one-way valve openingpressure and dispensed through the normally closed seam of the one-wayvalve and out of the dispenser.
 2. A dispenser as defined in claim 1,wherein the compression chamber is located axially with respect to theone-way valve and the actuator is located radially with respect to theone-way valve.
 3. A dispenser as defined in claim 1, wherein theactuator is approximately dome shaped.
 4. A dispenser as defined inclaim 1, further comprising an approximately annular securing membercoupled to the body and fixedly securing the valve cover thereto.
 5. Adispenser as defined in claim 1, wherein the flexible valve cover isresponsive to a flow of substance in the outlet aperture exceeding avalve opening pressure to move between (i) a normally-closed closedcondition, and (ii) an open condition wherein portions of the valvecover axially spaced relative to each other substantially sequentiallymove substantially radially relative to the valve seat to allow thepassage of substance through the seam and out of the dispenser.
 6. Adispenser as defined in claim 1, wherein the compression surface isdefined by one of (i) a piston located on the interior side of theactuator, and (ii) an interior wall of the actuator.
 7. A dispenser asdefined in claim 1, wherein the actuator includes a spring that biasesthe actuator in the direction from the second position toward the firstposition.
 8. A dispenser as defined in claim 7, wherein the spring isformed integral with the actuator.
 9. A dispenser as defined in claim 8,wherein the actuator is formed of an elastic material and the spring isdefined by a wall of the elastic actuator.
 10. A dispenser as defined inclaim 1, wherein the dispenser is adapted for dispensing a substancethat is at least one of a cosmetic and a pharmaceutical, and thedispensing portion includes an applicator surface defining a contoursubstantially conforming to a facial contour for facilitatingapplication of the substance thereto.
 11. A dispenser as defined inclaim 1, wherein at least one of an axial end portion of the valve coverand valve seat defines a substantially pointed portion for facilitatingrelease of substance therefrom.
 12. A dispenser as defined in claim 11,wherein the pointed portion is defined by the valve cover and extendsone of (i) radially inwardly, and (ii) radially outwardly.
 13. Adispenser as defined in claim 11, wherein: an axial end portion of thevalve seat extends axially outwardly over the valve cover; and the axialend portion of the valve seat defines at least one of a shape, surfacearea, coefficient of friction, and water absorption characteristic thatis selected based on a predetermined product to be dispensed to createthereon a substantially single drop of substantially predeterminedvolume of the predetermined product thereon upon actuating themanually-engageable actuator, and to release said substantiallypredetermined volume in a substantially single drop therefrom.
 14. Adispenser as defined in claim 1, wherein at least one of (i) the valvecover and valve seat define a decreasing degree of interferencetherebetween in a direction from an upstream end toward a downstream endof the seam, (ii) the valve cover defines a decreasing radial thicknessin a direction from an upstream end toward a downstream end of the seam,(iii) the valve seat defines an outer diameter that increases in adirection from an upstream end toward a downstream end of the seam, and(iv) the valve cover and valve seat define a configuration such that theenergy required to move respective segments in the valve coverprogressively decreases in a direction from an upstream end toward adownstream end of the seam.
 15. A dispenser as defined in claim 14,wherein the valve cover defines a decreasing radial thickness in adirection from an upstream end toward a downstream end of the seam. 16.A dispenser as defined in claim 1, wherein the variable-volume storagechamber is defined by a flexible member.
 17. A dispenser as defined inclaim 1, further comprising a lobe projecting adjacent to thecompression chamber that prevents fluid communication between thecompression chamber and the variably volume storage chamber duringmovement of the manually engageable surface in the direction from thefirst position toward the second position.
 18. A dispenser fordispensing a substance, comprising: first means for forming avariable-volume chamber for storing the substance; second means coupledin fluid communication with the first means for dispensing metereddosages of substance, and including third means for receiving a portionof the substance stored in the first means; fourth means forming anexternal portion of the dispenser coupled in fluid communication withthe second means (i) for normally sealing the second means along anannular, axially-extending seam and preventing the dispensing ofsubstance below a threshold pressure through the second means, and (ii)for substantially sequentially opening the seam in an axial directionthereof to allow the passage of substance at a pressure greater than thethreshold pressure through the second means and out of the dispenser;fifth means that is manually engageable and radially depressible betweenfirst and second positions relative to an elongated axis of thedispenser for pressurizing the substance in the third means, wherein thethird means is connectible in fluid communication between the firstmeans and the fourth means, and (i) during movement of the fifth meansin the direction from the second position toward the first position, thefirst means is in fluid communication with the third means forpermitting substance to flow from the first means into the third means,and (ii) during movement of the fifth means in the direction from thefirst position toward the second position, the third means is not influid communication with the first means and a portion of the fifthmeans extends into the third means for pressurizing substance within thethird means above an opening pressure of the fourth means and, in turn,dispensing the substance through the fourth means and out of thedispenser.
 19. A dispenser as defined in claim 14, wherein the firstmeans is a body portion of the dispenser; the second means is adispensing portion defining a portion of the third means, the thirdmeans is a compression chamber coupled in fluid communication betweenthe first means and the fourth means; the fourth means is a one-wayvalve including an axially-extending valve seat and an axially-extendingflexible valve cover seated on the valve seat and defining anormally-closed, axially-extending seam therebetween forming afluid-tight seal between the valve cover and valve seat; and the fifthmeans is a manually engageable, flexible actuator defining an undersidethat is receivable within the third means.
 20. A dispenser as defined inclaim 14, wherein the fifth means is located axially with respect to thefourth means and radially with respect to the third means, iselastically movable between the first and second positions, and isnormally biased in the direction from the second position toward thefirst position.